Pacemaker and Cardiothoracic Surgical Packs Recalled for Improper Sterilization Validation
American Contract Systems is recalling 24 units of pacemaker and cardiothoracic surgical packs distributed to health systems in multiple US states. Products were exposed to multiple sterilization cycles without proper validation.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall of implantable and surgical packs due to unvalidated multiple sterilization cycles. The hazard presents a risk of harm through potentially compromised device sterility, but no illnesses or injuries have been reported.
Plain-English summary
American Contract Systems, Inc. is recalling 24 units of various pacemaker packs and cardiothoracic surgical packs distributed to health systems and medical device distributors across the United States, including Arizona, Florida, Iowa, Illinois, Massachusetts, Minnesota, Missouri, Ohio, Nebraska, Pennsylvania, Rhode Island, South Dakota, and Texas.
The recalled packs were exposed to multiple sterilization cycles without validation that the sterilization process was appropriate for multiple exposures. This validation defect raises concerns about whether the devices maintain the sterility and safety standards required for implantable and surgical applications.
Health systems and distributors who received these products should identify and quarantine the affected units using the provided lot and serial numbers, then contact American Contract Systems for instructions on return, replacement, or destruction. The products should not be used in any implantation or surgical procedures.
Patients who have undergone procedures or received implants using these recalled packs should contact their healthcare provider for guidance, although the FDA has not reported any illnesses or injuries associated with this recall.
The recalled product
- Product
- Various Pacemaker Packs, Cardio Thoracic Packs
- Manufacturer
- American Contract Systems, Inc.
- Affected units
- 24
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Tray Number
- Sterilization Lot
- Lot Number
- Bag Serial Number 1) LSREPCUSTOML
- 2106181
- 835211
- 44251067 2) LSRCVBASING
- 2107102
- 817211
- 64116041 3) LSRSMVEINB
- 2107221
- 810211
- 64119459 4) LSRCFHENDAE
- 2107171
- 807211
- 64116602 5) UICT16E
- 2108183
- 771211
- 15066268 6) BHOH94I
- 2104141
Distribution
Part of a larger recall action
This product is one of 17 recalled by American Contract Systems, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 17 products in this recall →Related recalls
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